United States Pharmacopeia

The United States Pharmacopeia (USP) is the United States’ principal independent compendium of public quality standards for medicines and related substances. The name refers both to the pharmacopeia itself and, in common usage, to the nonprofit United States Pharmacopeial Convention that publishes and maintains it. The organization owns the USP trademark and the copyright in the pharmacopeia. Its central publication is the United States Pharmacopeia–National Formulary, generally abbreviated USP–NF, which combines drug standards from the United States Pharmacopeia with formulary standards from the National Formulary. USP was established in 1820 by a group of physicians who were concerned about inconsistent, adulterated, and unreliable medical preparations. Its earliest standards were practical preparation instructions, often based on botanical and other crude medicines used by apothecaries. As pharmaceutical manufacturing became more industrialized, USP moved away from recipe-style guidance toward modern compendial specifications and analytical procedures. These standards address such attributes as identity, strength, quality, purity, and consistency, and are supported by laboratory methods and physical reference materials. USP–NF standards have an important legal and regulatory function in the United States. When a drug substance or drug product has an applicable USP–NF monograph, the product is expected to meet the relevant public standard under federal drug law. A drug or ingredient whose recognized name is associated with a compendial standard may be considered adulterated if it fails to meet the required specifications. USP does not itself act as a government enforcement agency. Compliance is enforced by the U.S. Food and Drug Administration and other competent authorities, while manufacturers and regulators use USP standards as a common technical reference. The organization’s work extends beyond prescription medicines. USP develops standards for over-the-counter and animal medicines, dietary supplement ingredients and products, and food ingredients. Its Food Chemicals Codex provides internationally used specifications for substances such as preservatives, flavorings, colorants, nutrients, and other food chemicals. USP also maintains reference standards, which are characterized physical materials used in testing, and operates verification and audit programs. Products that successfully complete the organization’s dietary supplement verification program may carry the USP Verified mark; this is distinct from a manufacturer’s unaudited use of the letters USP to claim adherence to a standard. USP also supplies healthcare information and classification resources. At the request of the U.S. Department of Health and Human Services, it developed model therapeutic classification guidelines that could assist Medicare Part D prescription drug plans in organizing formularies. The organization issued multiple versions of those guidelines, with the final version referenced in the supplied material covering the 2015–2017 benefit years. Its international role has expanded through technical cooperation, standards agreements, offices, laboratories, and capacity-building programs. Since 1992, USP has worked with the United States Agency for International Development to help countries improve medicine-quality systems. The work initially operated as the Drug Quality and Information program and later developed into Promoting the Quality of Medicines (PQM). PQM has supported quality assurance, laboratory capacity, access to quality-assured medicines, and efforts against substandard and falsified products in countries across Africa, Asia, Europe and Eurasia, Latin America, and the Caribbean. USP has also entered cooperation arrangements with foreign pharmacopeial and regulatory bodies, including the Chinese Pharmacopoeia Commission, ASEAN-related institutions, and Russia’s Roszdravnadzor. International facilities and offices have included locations in Switzerland, Brazil, India, and China.

The United States Pharmacopeia emerged in 1820, when eleven physicians organized around a public-health problem: medicines in the United States varied widely in composition and quality. Apothecaries commonly prepared medicines from crude botanical materials and other substances, and the absence of consistent specifications made it difficult for practitioners and patients to know whether preparations were authentic, potent, or safe. The first USP standards therefore resembled recipes and preparation directions intended to promote greater uniformity. The development of industrial pharmaceutical manufacturing gradually changed the purpose and form of the compendium. As medicines increasingly came from specialized manufacturers rather than local apothecaries, USP standards evolved into formal specifications describing the expected identity, strength, purity, quality, and consistency of drug substances and products. Analytical tests became central to the system, allowing laboratories to determine whether a material conformed to a public standard. The organization consequently became less a manual of traditional formulations and more a scientific standards-setting institution. USP’s principal drug publication was ultimately combined with the National Formulary to create the USP–NF. The combined compendium contains monographs and general requirements used by manufacturers, testing laboratories, regulators, pharmacists, and other healthcare professionals. In the United States, federal law gives applicable USP–NF standards practical regulatory significance. Where a recognized drug substance or product has a relevant monograph, failure to meet the stated requirements can make the product legally adulterated. USP establishes and publishes the standards, but it does not investigate or prosecute noncompliance; those functions belong to the FDA and other government authorities. The scope of USP expanded beyond human prescription medicines. Its standards cover over-the-counter and animal drugs, as well as selected dietary supplements and food ingredients. USP’s acquisition of the Food Chemicals Codex from the Institute of Medicine in 2006 strengthened its role in food-ingredient quality. The codex provides specifications for categories including preservatives, flavors, colors, nutrients, and other food chemicals, and is used internationally even though it does not have the same general statutory status in the United States as USP–NF drug standards. USP also developed physical reference standards and verification services to complement written monographs. Reference standards are characterized materials used in analytical comparisons and quality testing. Through verification programs, USP can assess selected products and manufacturing systems against defined requirements. The USP Verified mark for dietary supplements indicates successful completion of the relevant verification process; it is not equivalent to a manufacturer simply printing USP on a label or asserting that it follows USP standards. The organization’s healthcare-information work has included drug classification guidance. Congress authorized the Secretary of Health and Human Services to request a classification system that Medicare prescription drug plans could use when developing formularies. USP produced six versions of its Model Guidelines, with the final version described in the supplied reference applying to the 2015–2017 benefit years. USP’s international public-health role became especially visible through cooperation with USAID. Beginning in 1992, the organization supported efforts to address poor-quality medicines through the Drug Quality and Information program. In 2009, a larger USAID cooperative agreement established Promoting the Quality of Medicines, or PQM. The program focused on strengthening quality-assurance and quality-control systems, increasing the availability of quality-assured medicines, reducing substandard and counterfeit products, and providing technical leadership and advocacy. The supplied reference says USP–USAID initiatives had assisted communities in more than 35 countries and operated across Africa, Asia, Europe and Eurasia, and Latin America and the Caribbean. USP has also pursued international technical relationships with other pharmacopeias, regulators, industry associations, and public-health institutions. Cooperation arrangements have included the Chinese Pharmacopoeia Commission, organizations associated with nine ASEAN countries, and Russia’s federal healthcare-surveillance authority. International offices and laboratories have operated in Switzerland, Brazil, India, and China. Today, USP remains an active nonprofit standards organization whose publications, reference materials, verification programs, and technical collaborations connect United States regulatory requirements with a broader global quality infrastructure.

• 2014

  Final USP Model Guidelines edition described

  [1]United States Pharmacopeiaen.wikipedia.org

  USP issued the final version of its Medicare-related Model Guidelines, intended for the 2015–2017 benefit years.

• 2013

  PQM agreement expanded

  [1]United States Pharmacopeiaen.wikipedia.org

  USAID extended the PQM program through September 2019, increased its funding, and broadened its geographic reach.

• 2009

  Promoting the Quality of Medicines launched

  [1]United States Pharmacopeiaen.wikipedia.org

  A larger USAID cooperative agreement created PQM as an expanded successor to the Drug Quality and Information program.

• 2006

  Food Chemicals Codex transferred to USP

  [1]United States Pharmacopeiaen.wikipedia.org

  USP obtained the Food Chemicals Codex from the Institute of Medicine, adding an established food-ingredient standards resource to its portfolio.

• 1992

  Cooperation with USAID began

  [1]United States Pharmacopeiaen.wikipedia.org

  USP began working with USAID on international efforts to improve the quality of medicines in developing countries.

• 1820

  United States Pharmacopeia organization formed

  [1]United States Pharmacopeiaen.wikipedia.org

  Eleven physicians established the organization to address inconsistent and poor-quality medical preparations in the United States.

An independent scientific authority and global reference point for pharmaceutical, food-ingredient, and dietary-supplement quality standards.

• Pharmaceutical compendium

  USP–NF

  The United States Pharmacopeia–National Formulary is USP’s principal combined compendium for drug quality standards. Its monographs and general chapters address the identity, strength, quality, purity, and consistency of human and animal medicines, including prescription and over-the-counter products where applicable standards exist. Manufacturers, laboratories, pharmacists, regulators, and other institutions use it as a common technical reference. Applicable standards also have legal significance under United States federal drug law, although enforcement is performed by government authorities rather than by USP itself.

• Analytical reference materials

  USP Reference Standards

  USP Reference Standards are physical materials used with compendial procedures to support analytical testing. Laboratories and manufacturers compare tested substances with these characterized materials when assessing identity, purity, strength, or other quality attributes. They complement the written requirements in USP–NF and related compendia by providing a practical basis for laboratory measurement and method verification.

• Food-ingredient standards

  Food Chemicals Codex

  The Food Chemicals Codex is an international compendium of specifications for food ingredients, including preservatives, flavorings, colorants, nutrients, and related substances. USP obtained the publication from the Institute of Medicine in 2006. Its standards are used internationally and have been incorporated by reference into numerous food regulations, although the supplied reference notes that the codex does not have general statutory recognition in the United States.

• Product verification

  USP Verified Dietary Supplement Program

  This program evaluates participating dietary supplement products and related manufacturing controls against USP requirements through testing and auditing. Products that satisfy the program’s conditions may display the USP Verified mark. The mark represents participation in a verification process and should be distinguished from the unaudited use of USP letters by a manufacturer to claim that it follows a USP standard.

• Healthcare practice standard

  USP <800>

  USP <800> is an example of a USP publication focused on the safe handling of hazardous drugs. It illustrates the organization’s broader role in developing practice and quality standards in addition to traditional drug monographs.

• 2009Promoting the Quality of Medicines

  Africa · Asia · Europe and Eurasia · Latin America and the Caribbean

  PQM was established under an expanded USAID cooperative agreement to strengthen quality-assurance and quality-control systems, increase access to quality-assured medicines, combat substandard and counterfeit medicines, and provide technical leadership.

  Outcome. The supplied reference reports that USP–USAID cooperation helped communities improve medicine quality in more than 35 countries.

  Source
• 1992Drug Quality and Information

  Africa · Asia · Europe and Eurasia · Latin America and the Caribbean

  USP began a cooperative effort with USAID to help developing countries address poor-quality medicines and strengthen medicine-quality infrastructure.

  Outcome. The initiative later developed into the broader Promoting the Quality of Medicines program.

  Source

• 2009

  Expansion from DQI to PQMStrategy

  Background

  Growing international demand for stronger medicine-quality systems led USAID and USP to broaden their earlier Drug Quality and Information cooperation.

  Action taken

  USP established Promoting the Quality of Medicines as an expanded program focused on quality systems, supply, anti-counterfeit work, and technical advocacy.

  Aftermath

  PQM became a major vehicle for USP’s international technical-assistance work across multiple regions.

  Source

• 2006

  Acquisition of the Food Chemicals CodexM&A

  Background

  The Institute of Medicine had published the first five editions of the Food Chemicals Codex before transferring the publication to USP.

  Action taken

  USP obtained the Food Chemicals Codex and incorporated it into its food-ingredient standards activities.

  Aftermath

  The codex became one of USP’s major resources for international food-ingredient quality specifications.

  Source

1. 1United States Pharmacopeiaen.wikipedia.org
2. 2United States Pharmacopeia official websiteusp.org